The following data is part of a premarket notification filed by Porges S.a. with the FDA for Proges Folysil Silicone Foley Catheter, Straight Cylindrical Tip, Silicone Female Foley Catheter, Straight Cylindrical,.
| Device ID | K013174 |
| 510k Number | K013174 |
| Device Name: | PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL, |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | PORGES S.A. USINE DU PONTET BP 89 Sarlat, FR 24203 |
| Contact | Bernard Ismael |
| Correspondent | Bernard Ismael PORGES S.A. USINE DU PONTET BP 89 Sarlat, FR 24203 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-24 |
| Decision Date | 2002-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03600040132395 | K013174 | 000 |
| 03600040128916 | K013174 | 000 |
| 03600040128787 | K013174 | 000 |
| 03600040128657 | K013174 | 000 |
| 03600040128527 | K013174 | 000 |
| 03600040128398 | K013174 | 000 |
| 03600040128268 | K013174 | 000 |
| 03600040128008 | K013174 | 000 |
| 03600040127872 | K013174 | 000 |
| 03600040127742 | K013174 | 000 |
| 03600040127612 | K013174 | 000 |
| 03600040127506 | K013174 | 000 |
| 03600040127377 | K013174 | 000 |
| 03600040127247 | K013174 | 000 |
| 03600040127117 | K013174 | 000 |
| 03600040126981 | K013174 | 000 |
| 03600040129043 | K013174 | 000 |
| 03600040129173 | K013174 | 000 |
| 03600040132265 | K013174 | 000 |
| 03600040132135 | K013174 | 000 |
| 03600040132005 | K013174 | 000 |
| 03600040131725 | K013174 | 000 |
| 03600040131657 | K013174 | 000 |
| 03600040130421 | K013174 | 000 |
| 03600040130315 | K013174 | 000 |
| 03600040130209 | K013174 | 000 |
| 03600040130094 | K013174 | 000 |
| 03600040129982 | K013174 | 000 |
| 03600040129876 | K013174 | 000 |
| 03600040129760 | K013174 | 000 |
| 03600040129654 | K013174 | 000 |
| 03600040129548 | K013174 | 000 |
| 03600040129302 | K013174 | 000 |
| 03600040126851 | K013174 | 000 |